Intraoperative Intraportal Chemotherapy Combined With Adjuvant Chemotherapy for Stage II and III Colorectal Cancer

December 10, 2013 updated by: Xu jianmin

A Prospective,Randomized Control Trial of Intraoperative Intraportal Chemotherapy (5-FU and Oxaliplatin) Combined With Adjuvant Chemotherapy to Prevent Liver Metastasis in Patients Receiving Curative Colorectal Cancer Resection.

In this study, the investigators assessed whether intraoperative Intraportal infusion of 5-FU and oxaliplatin is able to prevent liver metastasis in patients receiving curative colorectal cancer resection.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this study, the investigators assessed whether intraoperative Intraportal infusion of 5-FU and oxaliplatin is able to prevent liver metastasis and improve survival in patients with Stage II or Stage III colorectal cancer without apparent liver metastasis based on a thorough preoperative evaluation.

Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms.Arm A: 5-FU 1g and oxaliplatin 100mg + curative resection (study group, n=132). Arm B: curative resection alone (control group, n=132).Follow-up: X-ray, US, CT, blood test, colonoscopy,every 3months.

The study endpoints were disease-free survival, overall survival, and liver metastasis-free survival as evaluated by intent-to-treat analysis.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  1. Age ≥ 18 and ≤ 75 years and with histologically proven adenocarcinoma of the colon or rectum
  2. WHO performance status of 0 or 1
  3. Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included colonoscopy and an abdominal computed tomography (CT) scan
  4. Written informed consent for participation in the trial.

Exclusion criteria

  1. has prior other malignant cancer
  2. has severe major organ dysfunction
  3. has prior cancer therapy before surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ARM A
Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. In ARM A, patients accepted intraoperative intraportal infusion of 5-FU 1g and oxaliplatin 100mg + curative resection+mFOLFOX6.
Drug: 5-FU and oxaliplatin
Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. In arm A, patients accepted intraoperative intraportal infusion of 5-FU 1g and oxaliplatin 100mg+ curative resection + mFOLFOX6.
Procedure: colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6)
Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. All patients in both arms accept curative resection of colorectal cancer,and accept standard adjuvant chemotherapy (mFOLFOX6).
ACTIVE_COMPARATOR: ARM B
Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. In arm B, patients accepted curative resection + mFOLFOX6 alone.
Procedure: colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6)
Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. All patients in both arms accept curative resection of colorectal cancer,and accept standard adjuvant chemotherapy (mFOLFOX6).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3 years disease-free survival
Time Frame: 3 years after operation
PFS will be defined as the period from the first day of CRC resection to the date of disease recurrence or to death.
3 years after operation

Secondary Outcome Measures

Outcome Measure
Time Frame
3 years overall survival and metastasis-free survival
Time Frame: 3 years after operation
3 years after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xu jianmin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ANTICIPATED)

September 1, 2015

Study Registration Dates

First Submitted

September 23, 2013

First Submitted That Met QC Criteria

October 24, 2013

First Posted (ESTIMATE)

October 30, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Octree Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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